U.S. patent number 5,868,758 [Application Number 08/873,852] was granted by the patent office on 1999-02-09 for method apparatus and kit for performing hair grafts.
Invention is credited to Barry S. Markman.
United States Patent |
5,868,758 |
Markman |
February 9, 1999 |
Method apparatus and kit for performing hair grafts
Abstract
A method, device and kit for preforming multiple hair transplant
grafts disclosed. The device includes a plurality of cutters
adapted to make a pattern of incisions in the tissue to receive the
grafts. A dilator device preferably comprises interengaging plates.
A first plate includes a number of downwardly extending spikes for
extension through a number of downwardly extending hollow catheters
of a second plate. The first and second plates are pressed together
with the interengaging spikes and catheters to define dilators of a
pattern corresponding to the pattern of incisions. The dilators are
inserted into the incisions and the first plate is removed, leaving
the hollow catheters of the second plate in the tissue. A third
plate filled with hair grafts is sleeved into or aligned with the
catheters of the first plate. The hair grafts are pressed downward
through the third plate, through the first plate catheters, into
the tissue. The kit includes the incision device and dilator
device.
Inventors: |
Markman; Barry S. (Las Vegas,
NV) |
Family
ID: |
25362458 |
Appl.
No.: |
08/873,852 |
Filed: |
June 14, 1997 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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561018 |
Nov 21, 1995 |
5792169 |
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395455 |
Feb 28, 1995 |
5643308 |
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Current U.S.
Class: |
606/133;
606/187 |
Current CPC
Class: |
A61F
2/10 (20130101); A61B 17/3468 (20130101) |
Current International
Class: |
A61B
17/34 (20060101); A61F 2/10 (20060101); A61B
017/34 () |
Field of
Search: |
;606/1,131-133,183,187
;623/15 ;604/57,59-64,173,164,264,117 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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1595597 |
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Jun 1970 |
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FR |
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1267784 |
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May 1968 |
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DE |
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2809327 |
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Apr 1979 |
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DE |
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Other References
Article entitled "Micrograft Dilators: In Pursuit of the
Undetectable Hairline," published in J. Dermatol. Surg. Oncol.
14:3, Mar. 1988. .
Pages from Robbins Instruments Inc. supply catalog, circa unknown,
showing Marritt dilators..
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Primary Examiner: Lewis; William
Attorney, Agent or Firm: Quirk & Tratos
Parent Case Text
RELATED APPLICATION DATA
This application is a continuation-in-part of U.S. patent
application Ser. No. 08/561,018, filed Nov. 21, 1995 U.S. Pat. No.
5,792,169 which was a continuation in part of application Ser. No.
08/395,455 filed Feb. 28, 1995 U.S. Pat. No. 5,643,308.
Claims
I claim:
1. A method for implanting hair grafts comprising:
providing a device adapted to locate a predetermined pattern of
tissue dilators in the tissue to maintain the tissue dilated to
receive a hair graft;
providing an incision device having a body and a plurality of
incising cutters disposed in a pattern corresponding to the dilator
pattern;
making a plurality of incisions with the incision device, said
incisions corresponding to the pattern of the cutters;
registering the dilator locating device with the incision
pattern;
locating the dilators in the incisions; and
depositing the hair graft in the dilated incision.
2. The method of claim 1 including providing a device having a
first template with a plurality of downwardly extending guide means
having passages therethrough and a second template having a
plurality of downwardly extending spikes adapted to be received
into the passages to define with the guide means said dilators,
locating the defined dilators in the incisions, removing the spikes
from the guide means and depositing the hair grafts through the
passages into the tissue.
3. The method of claim 1 including providing an incision device
having a plurality of blades with knife edges for making said
incisions.
4. The method of claim 3 including providing an incision device
having a plurality of blades with knife edges, adjacent blades
being of different lengths.
5. The method of claim 3 including providing an incision device
having a plurality of blades with knife edges for making said
incisions, each of said edges having an edge width of between 0.055
and 0.060 inches.
6. A kit for performing hair grafting in tissue comprising:
a dilator having a first template with a pattern of a plurality of
downwardly extending guide means having passages therethrough and a
second template having a plurality of downwardly extending spikes
adapted to be received into the passages to define with the guide
means dilators;
an incision device having a plurality of cutters disposed in a
pattern corresponding to the pattern of said guide means; the
cutters adapted to incise the tissue to receive the guide means;
and
means for depositing a graft through the passages of the guide
means into the tissue.
7. The kit of claim 6 wherein the cutters are knife edges.
8. The kit of claim 7 wherein the knife edges are of different
lengths.
9. A device for preforming a pre-incision to receive a hair graft
deposited using a dilator device which includes a first template
with a pattern of a plurality of downwardly extending guide means
having passages therethrough and a second template having a
plurality of downwardly extending spikes adapted to be received
into the passages to define with the guide means a predetermined
pattern of dilators, said grafts deposited through the passages
into the graft site tissue, the device including:
a body;
a plurality if cutters disposed on and protecting from the body in
a pattern corresponding to the pattern of dilators, each cutter
adapted cut an incision in the incision to receive a dilator; and a
guide block having a surface to rest on the tissue and a guide
surface, said body and guide surface cooperating to guide the
incising of the tissue.
10. The device of claim 9 further including sliding guides coacting
between the body and guide surface to guide the incising of the
tissue.
11. The device of claim 10 wherein the sliding guides include a
groove and a rudder on said guide surface and body, said rudder and
grooves cooperating to guide the incising of the tissue.
Description
FIELD OF THE INVENTION
The present invention relates to the placement of hair grafts. In
particular, the invention is a method, apparatus and kit for
preforming hair grafts and more particularly to forming
pre-incisions to receive dilators for the grafts.
BACKGROUND OF THE INVENTION
Hair transplants have become commonplace over the last few years.
In one of the newest technique of transplanting hair, small
"grafts" of tissue containing only a few hairs are placed in sites
on a recipient's scalp.
In particular, hair from other portions of the recipient are cut
into very small cylindrical sections, or grafts. The recipients
scalp is anesthetized, and then expanded by infusing saline into
the scalp beneath the galeal layer. The surgeon inserts a
needle-like dilator through the scalp, including the galeal layer,
forming a cavity. The dilator is removed, and a donor graft is
inserted into the cavity.
The success rate of this technique depends primarily upon whether
the dilator succeeds in forming a cavity which extends below the
galeal layer, and upon the time lapse between preparation and
insertion of the graft.
New techniques in hair grafting require a large number, often 200
to 600, grafts to be placed during a single session. In the present
technique, dilators are individually placed by hand. This is not
only time consuming, but is inexact, since the surgeon places the
dilators essentially randomly.
In order for the transplanted hair have a uniform look and proper
coverage, however, the grafts must be arranged on the scalp in
specific patterns. For example, numerous small grafts are often
placed near the hairline, while larger grafts are placed less
densely on the top and rear of the scalp.
A need exists for a method of easily forming cavities into which
hair grafts are inserted and for controlling their location and
number of dilators inserted across the entire scalp. Further there
is a need for devices and methods for locating and easily inserting
a pattern of tissue dilators to receive the grafts.
SUMMARY OF THE INVENTION
The present invention is a method, apparatus and kit for forming a
number of cavities in the tissue of a patient into which hair
grafts are inserted.
According to the present invention, means are provided for dilating
the tissue to receive the graft. These means may include a
cartridge having a four-sided, walled housing having open top and
bottom ends. A template or guide is removably located in the
housing, recessed from a bottom edge of the housing. A plurality of
passageways are located through the guide for containing a
plurality of dilators in a predetermined grid pattern therein.
The dilators are releasably retained in the passageways of the
guide by friction between the dilators and the guide. Each dilator
includes a lower or proximal probe portion for insertion into the
scalp and an upper or distal grip portion by which the surgeon
grasps the dilator. The distal grip portion is smaller in outer
dimension than the probe portion.
The distal end of the dilators faces the top end of the housing,
and the proximal end of the dilators faces the bottom end of the
housing. A depressor is located over the open top end of the
housing proximate the distal end of the dilators.
A surgeon places the cartridge on the patient's scalp with the
bottom edge of the housing resting on the patient's head. The
surgeon presses downwardly on the depressor, forcing the dilators
downwardly out of the guide into the tissue of a patient. Once the
dilators are inserted, the housing is removed from the scalp. The
dilators are then removed as a graft is deposited into the opening
provided thereby.
In a variation of this form of the present invention, the depressor
of the dilator device is a plunger connected to an actuator. In
this form of the invention, the housing of the cartridge is adapted
to engage the triggering mechanism of an actuating mechanism, and
triggering of the mechanism causes the actuator to depress the
plunger, forcing the dilators from the guide into the tissue.
In other forms of the dilator device, the housing is a cylindrical
and rotatable with respect to a base member which adapted for
insertion into a triggering mechanism. The housing includes a
plurality of passages therein in which dilators are located. An
actuating member passes from the base member through the housing to
a plunger located proximate a first end of the dilators located in
the passages. When a surgeon triggers the mechanism, one or more
dilators are forced out of the passages into the tissue of a
patient. The surgeon then rotates the housing with respect to the
base, aligning another passage for actuation by the firing
device.
In another form of the dilator device, the device for forming
dilating the tissue comprises a female template having a number of
downwardly depending guides with passages therethrough, along with
a mating male template having a number of downwardly depending
spikes. When engaging one another, the spikes of male template pass
through the passages in the guides of the female template, forming
a single template with downwardly extending "dilators."
In use, a surgeon presses the dilators of the combined male and
female templates into the tissue of a patient. The surgeon removes
the male template, leaving the female template in place dilating
the tissue. The surgeon then presses a third template having
downwardly extending hollow guides each containing a hair graft
into the female template. The surgeon presses the spikes of the
male template through the guides of the third and female templates,
pressing the hair grafts downwardly. Then the surgeon removes the
templates, leaving the hair grafts positioned in the tissue.
In another version, the dilator device for creating apertures in
the tissue and placing the hair grafts comprises four interengaging
plates. An incision catheter plate comprises a base having a number
of downwardly extending hollow catheters aligned with bores in the
base. An incision needle plate comprises a base having a number of
downwardly extending spikes for extension into the catheters of the
incision catheter plate. A hair graft catheter plate comprises a
base having a number of downwardly extending hollow catheters
aligned with bores in the base. A hair a graft needle plate
comprises a base having a number of downwardly extending rods.
Posts extend upwardly from the incision catheter plate for
engagement with bores in each of the other plates for aligned
stacking of the plates.
In use, the user presses the incision needle plate and incision
catheter plate together until the spikes extend just beyond the
open end of the catheters. The user presses the plates downwardly
so that the spikes/catheters extend into the tissue of a patient.
The user removes the incision needle plate, leaving the catheters
of the incision catheter plate located in the tissue.
The user presses the hair graft catheter plate (with hair grafts
loaded into each catheter) downwardly until the catheters thereof
are located in the catheters of the incision catheter plate. The
user then presses the hair graft needle plate downwardly so that
the rods thereof extend into the catheters of the hair graft
catheter plate, thus pressing the hair grafts downwardly to deposit
them in the tissue. The user then removes all of the plates,
leaving the hair grafts in the tissue of the patient.
In another, and the preferred, version of the present invention,
the dilating device for use in creating apertures and placing the
hair grafts comprises a lower plate, upper plate, and at least one
cartridge. Hollow catheters in the preselected graft pattern extend
from the lower plate, and are aligned with bores passing
therethrough. Spikes extend downwardly from the upper plate, which
is movably mounted above the lower plate. The cartridge is located
between the upper and lower plate. In a first form, the cartridge
comprises a rotatable wheel having several sets of bores which are
alignable with the catheters/spikes. In a second form, the
cartridge comprises a small individual plate having a set of bores
therein. Means are provided for aligning the bores in the
cartridge(s) with the spikes catheters.
In use, a user presses the upper plate downwardly, extending the
spikes thereof through empty bores in the cartridge and the
catheters. The user then presses the entire device downwardly until
the interengaging spikes/catheters extend into the tissue of the
patient in the predetermined and desired graft pattern. The user
then lifts up on the upper plate, and either inserts a loaded
cartridge or rotates the cartridge, so that bores filled with hair
grafts are aligned with the catheters. The user then presses the
upper plate downwardly, pressing the hair grafts into the catheters
and therethrough into the tissue. The user then removes the device,
leaving the hair grafts in the tissue of the patient.
In this form, the user may preload large numbers of hair grafts
into the cartridge(s), thereby allowing him to place large numbers
of grafts in uninterrupted fashion.
To provide for the location of the dilators by whatever version
described above, the present invention includes a method and device
for making pre-incisions in the tissue to receive the dilators. The
pre-incision device includes a body with a plurality of projecting
cutters in a pattern to match the predetermined pattern of the
dilators and the desired graft pattern. The surgeon selects the
appropriate pattern for the incision device which matches the
pattern for the dilators and grafts and depresses it to form a
pattern of incisions in the tissue to receive the dilators.
Pre-incision is useful particularly where there are a large number
of dilators. Because of the distribution of the forces, penetrating
the tissue using the dilators may be difficult. By providing the
pre-incisions, the dilators can easily be inserted into the
pre-made incisions in the tissue. Further, it is believed that the
pre-incisions will promote healing in that a clean, smooth incision
is made.
To guide the use of the incision device, a guide block may be
provided. The guide block is adapted to rest on adjacent tissue,
i.e. the scalp, to support and guide the movement of the device to
make the incision. Guide surfaces can be provided whereby the
device may be registered and indexed to make adjacent patterns of
incisions.
According to a further aspect of the present invention, a kit is
provided which includes the dilating and incision devices described
above to be used in locating and depositing hair grafts.
The method according to the present invention includes making the
incisions with the incision device, inserting the dilators into the
pattern of incisions made and depositing the grafts.
Further objects, features, and advantages of the present invention
over the prior art will become apparent from the detailed
description of the drawings which follows, when considered with the
attached figures.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a single dilator for use in the
present method;
FIG. 2 is a perspective view of the dilator of FIG. 1 inserted into
the scalp of a patient;
FIG. 3 is a perspective view of the dilator of FIG. 2 being removed
from the scalp, and being replaced by a hair graft;
FIG. 4 is a partial perspective view of a manually operated
multiple-dilator placing cartridge in accordance with the present
invention; and
FIG. 5a is a front end view of the cartridge of FIG. 4 with a
depressor thereof in a first, retracted position;
FIG. 5b is a front end view of the cartridge of FIG. 4 with a
depressor thereof in a second, depressed position;
FIG. 6 is a perspective view of a patient's scalp, illustrating
that certain portions of the scalp require differing hair graft
sizes and densities, and thus differing sized dilators and dilator
insertion points;
FIG. 7 is a perspective view of a second embodiment of the present
invention, illustrating an automated revolving single-shot dilator
cartridge;
FIG. 8 is a perspective view of a third embodiment of the present
invention, illustrating an automated rotating multiple shot dilator
cartridge;
FIG. 9 is a top view of a fourth embodiment of the present
invention illustrating an automatically operated dilator insertion
cartridge;
FIG. 10 illustrates a second form of dilator for use in the methods
and devices of the present invention;
FIG. 11 is a partial perspective view of a male and a female
template of a fifth form of the invention;
FIG. 12 is a cross-sectional side view of the male and female
template of FIG. 11 shown engaging one-another and pressed into the
tissue of a patient; and
FIG. 13 is a cross-sectional side view of a third template engaging
the female template of FIG. 11, with the male template engaging the
third template.
FIG. 14a is a perspective view of an incision catheter plate of a
sixth form of the present invention;
FIG. 14b is a perspective view of an incision needle plate of a
sixth form of the present invention;
FIG. 14c is a perspective view of a hair graft catheter plate of a
sixth form of the present invention;
FIG. 14d is a perspective view of a hair graft needle plate of a
sixth form of the present invention;
FIG. 15 is a side view illustrating the interengagement of the
incision needle plate and incision catheter plate;
FIG. 16 is a side view illustrating use of the incision needle
plate and incision catheter plate for forming multiple cavities in
tissue of a patient;
FIG. 17 is a side view illustrating interengagement of the hair
graft needle plate, hair graft catheter plate, and incision
catheter plate, whereby hair grafts are pressed from the hair graft
catheter plate into cavities formed in the tissue;
FIG. 18 is a perspective view of a device of the seventh form of
the present invention;
FIG. 19 is a perspective view of an alternative embodiment of the
device of the seventh form of the present invention.
FIG. 20 is a perspective view of the incision device and guide
block according to the present invention;
FIG. 21 is a side view of the incision device of FIG. 20; and
FIGS. 22A-C are views of various embodiments of the incision device
of FIG. 20.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The present invention involves methods, devices and kits for
implanting hair grafts. Broadly the present invention is directed
to methods, devices and kits which include means for dilating the
tissue in a preselected pattern to receive grafts, for pre-incising
the tissue in a pattern corresponding to the dilator pattern to
receive the dilators and the deposition the grafts in the dilated
tissue.
Before describing the incision device of the present invention, I
will describe various dilators for use with such devices and in the
kit and method of the present invention. As described, the dilators
can be used with or without the incision device as hereinafter
described. When the dilator devices are used without the incision
device, the dilators themselves are used to puncture the
tissue.
FIG. 1 illustrates a dilator 20 for use in some of the methods and
devices of the present invention. In general, the dilator 20
comprises a distal handle portion or end 22 and a proximal probe
portion or end 24. Preferably, the very end of the handle portion
is blunt, and the very end of the probe portion is pointed. As
illustrated in FIG. 2, the dilator 20 is inserted in the tissue of
a patient, normally the scalp, for creating an cavity into which a
hair graft 26 is inserted. In a first method in accordance with the
present invention, a number of dilators 20 are simultaneously
located in the tissue when a surgeon manually presses on a
dilator-engaging depressor 38, pushing a number of dilators through
a guide 36 into the scalp, as illustrated in FIGS. 5a and 5b.
In a second method, a series of single dilators 20 are inserted
into a scalp upon actuation of a gun or other remote triggering
device, via the cartridge illustrated in FIG. 7. In a third method,
multiple dilators 20 are inserted into the scalp when a surgeon
actuates a gun, via the cartridge illustrated in FIG. 8.
In a fourth method, a number of dilators 20 are simultaneously
inserted into the scalp when a surgeon triggers an actuating
mechanism connected to the cartridge 300 illustrated in FIG. 9.
In a fifth method, the interengaging templates illustrated in FIGS.
11-13, which include downwardly depending dilating spikes and
guides, are used to penetrate and be inserted into the tissue and
form open cavities into which hair grafts are inserted.
More particularly, and referring again to FIGS. 1-3, in a first
form, the dilators 20 of the present invention are preferably
cylindrical in shape, and about 2 cm long from end to end. In
particular, the handle portion 22 is about 1 cm long and about 0.5
mm in diameter. The probe portion 24 is about 1 cm long and has a
larger diameter than the handle portion, being about 1 mm in
diameter. The dilator 20 tapers to a sharp point at the very end of
the probe portion for piercing and penetrating tissue, over about
the last 0.25 cm of the dilator.
Most importantly, because the handle portion 22 of the dilator 20
has a smaller outer dimension that the probe portion 24, a cavity
which is large enough to accept a hair graft is formed when the
dilator is inserted into the scalp, and yet a sufficient distance
between the handles exists to allow the surgeon to grasp them and
work between them.
FIGS. 1-3 illustrate, in overview form, use of a single dilator 20
to facilitate hair graft 26 insertion. First, the dilator 20 is
pressed downwardly into the scalp 28 into the galeal layer 30.
Penetration of the scalp 28 is facilitated by the tapered end of
the dilator 20 and the pre-incision according to the present
invention.
Once inserted into the tissue of a patient, the enlarged probe
portion 24 expands the surrounding tissue, as illustrated in FIG.
2. After insertion, the surgeon removes the dilator 20 as
illustrated in FIG. 3, leaving an cavity into which the surgeon
inserts the hair graft 26. The resiliency of the tissue ultimately
causes the tissue around the hair plug 26 to close, securing the
graft in place.
FIG. 4 illustrates a manually operated device for use in placing
multiple dilators 20 in accordance with a first method of the
present invention. In accordance with this method, by manual
effort, a surgeon simultaneously places a number of dilators 20 in
a predetermined arrangement. The device for accomplishing the
method is a cartridge 32 which comprises outer support means in the
form of a housing 34 having the form of a contiguous upright wall,
a dilator guide 36, and a depressor 38 (see FIGS. 5A and 5B).
The housing 34 of the cartridge 32 is preferably square or
rectangular in shape. The particular size, in inner dimension and
thickness, varies on the number of dilators to be placed and their
size. When four-sided, the housing 34 has a first side 56, a second
side 58, a third side 60, and a fourth side 62, and an open top end
39 and bottom end 40.
Preferably, the first, second and third sides 56, 58, 60 are
rigidly connected, forming a "C"-shaped member. The fourth side 62
is movably or removably connected to the other sides. In
particular, the edges of the first and second sides 56, 58 which
engage the fourth side 62 include a "C"-shaped channel. The fourth
side 62 has inwardly facing tabs 64, 66 (66 not visible) on
opposing edges which slide in the channels of the first and second
sides 56, 58. The fourth side 62, as illustrated in FIG. 4, is thus
detachably connected to the first and second sides 56, 58.
Preferably, a stop 68 in the form of a solid member covering the
top end of the channels 64, 66, limits downward movement of the
fourth side 62 on the first and second sides 56, 56. When connected
to the first and second sides, the fourth side completes the
contiguous wall comprising the housing 34.
Each of the sides is made of plastic, or a similar durable and
sterilizable material. When made of plastic, the first, second, and
third sides 56, 58, 60 can be molded as a single piece.
Dilator guide means in the form of a guide or template 36 are
located in the cartridge, recessed a short distance up from a
bottom edge 41 of the housing 34 on the interior thereof. The
particular recess distance is chosen so that when the cartridge 32
is placed on the scalp, the tips of the dilators 20 located in the
cartridge 32 are proximate the scalp, as illustrated in FIG.
5a.
The dilator guide 36 is a rectangular member having first and
second ends or sides which engage a first groove 44 in the first
side 56 of the wall 34, and a second groove 46 in the opposite
second side 58 of the wall. The grooves 44, 46 are recessed areas
in each of these two sides 56, 58 having approximately the same
height as the thickness of the guide. The engagement of the guide
36 with the grooves 44, 46 supports the guide in the housing 34
above the bottom end thereof.
The guide 36 is preferably made of a slightly flexible material,
such as rubber, and includes a plurality of passages 42
therethrough. As illustrated in FIG. 4, the passages pass through
the guide 36 at about a 30 degree angle with respect to vertical.
The passages 42 can be arranged in a variety of patterns, depending
on the particular dilator placement pattern desired.
Each passage 42 is sized to accept a dilator. When the dilators 20
have the shape described above, the passage 42 is circular in
shape, having approximately the same diameter as the larger probe
portion of the dilator 20.
Stop means retain the dilators in the guide 36 in a first position.
Preferably, the stop means comprises friction between the dilators
and the guide 36. In particular, the size of the passage 42 and the
type of material from which the guide 36 is selected so that a
dilator 20 placed in a passage is retained therein unless pushed
through by an outside force. As illustrated in FIG. 4, the passage
size varies when the dilator size varies, such that an individual
cartridge can contain a guide having passages of differing
sizes.
The depressor 38 is located near the top end 39 of the housing 34,
and has a top surface 48, bottom surface 50, and two opposing edges
each having an outwardly extending tab 52a,b thereon. The top
surface 48 is preferably flat and smooth for engagement with the
thumb 49 or finger of a surgeon. The bottom surface 50 is "stepped"
providing a number of individual surfaces arranged parallel to the
end of each dilator.
The tabs 52a,b are thin members extending outwardly along opposite
edges of the depressor. The tabs 52a,b each engage a corresponding
ledge 54a,b on the first and second sides 56, 58 of the housing,
acting as means for supporting the depressor 38 above or at the
ends of the dilators 20 in a first raised position. When a surgeon
presses upon the depressor, however, the tabs 52a,b break off,
allowing the depressor 38 to move downwardly within the wall 34 of
the cartridge 32.
In the first method, a surgeon uses the cartridge 32 of the present
invention to simultaneously place a number of dilators 20. First,
the surgeon lifts the fourth side 62 upwardly, exposing the
interior portion of the cartridge 32. The surgeon presses a dilator
guide 36 into the cartridge, the particular guide chosen to have
the desired, preselected, dilator insertion pattern required for
that portion of the scalp in which hair grafts are to be
inserted.
FIG. 6 illustrates in overview schematic form how hair grafts 26 of
different sizes are placed in differing regions of the scalp. Along
the normal hair line, many small grafts are inserted. In the
central or interior portion of the scalp, larger hair grafts are
inserted. Thus, not only does the "density" of the dilators being
placed need to vary, but their size often must vary as well.
Once a guide 36 having the desired dilator pattern (in both size
and density) is chosen, it is inserted into the cartridge, and the
fourth side 62 is pressed downwardly. When relocating the fourth
side, the channels 64, 66 slide along and engage the edges of the
first and second sides 56, 58, until the stops 68 prevent further
downward movement of the side.
Preferably, the appropriately sized dilators 20 are already
inserted into the passages 42 in the guide 36 when the guide is
inserted. If not, the surgeon inserts dilators into the passages
42.
The surgeon then places the cartridge 32 on the scalp in the
desired position, as illustrated in FIG. 5a. In this position, the
dilators 20 are located proximate the scalp.
The surgeon then presses downwardly on the depressor 38. Pressure
on the depressor breaks off the tabs 52a,b on the edges of the
depressor, allowing the depressor to slip downwardly past the
ledges 54a,b on the first and second sides 56, 58 of the wall
34.
The depressor, which engages the handle portions 22 of the dilators
20, presses them downwardly into the scalp. As described below, the
dilators 20 are inserted into incisions made with the incision
device of the present invention. Eventually, further movement of
the depressor 38 is prevented by its contact with the guide, as
illustrated in FIG. 5b.
The cartridge 32 is then removed, leaving the dilators in place in
the incisions in the scalp. The cartridge 32 is easily removed
without disrupting the dilators 20 because the dilators no longer
engage the guide because the small diameter handle portion 22 of
each dilator 20 is all that remains in the larger passages 42 of
the guide. Then, as illustrated in FIGS. 2 and 3, the surgeon
removes the dilators and inserts hair grafts 26 in their place,
completing the transplant process.
Preferably, the range of movement of the depressor 38 against the
dilators 20 equals the distance the dilators 20 must be pressed
into the scalp for optimum hair graft insertion. In the case where
the dilators 20 initially just contact the tissue when the
cartridge is set on the patient, this distance is normally about 7
mm. Thus, the depressor's 38 range of movement against the dilators
is about 7 mm.
The cartridge 32 of the present invention is reusable. In
particular, the surgeon removes the old used depressor 38 from the
cartridge and replaces it with a new one having intact tabs 52a,b.
When a new depressor 38 is installed, it is again supported by the
tabs 52a,b the ledges 54a,b in a raised position.
The surgeon then either inserts new dilators 20 into the passages
42 of the guide, or replaces the guide 36 in the cartridge with a
different one if a different dilator insertion pattern is
desired.
The above description represents one embodiment of the dilator
device according to the present invention. However, many variations
to the method and device are possible without deviating from the
scope of the invention.
For example, the cartridge 32 can have any of a variety of shapes
and sizes. Further, the guides can have a variety of sized and
spaced dilator accepting passages.
As a further aspect, the guide may actually comprise a number of
individual elements which are arranged together to form a single
grid or element in the cartridge. In this fashion, the guide may be
"customized" using only a few guides having fixed patterns. For
example, the guides may comprise elongate members having a single
row of passages therein, such that when a number of guides are
placed together, a grid having numerous rows of differently spaced
and sized passages results.
While it is desirable that the passages pre-formed in the guide,
the guide may be made of a pliable material, whereby the surgeon
can form the passages simply by pressing dilators into the guide in
any desired pattern.
Further, while the passages in which the dilators are located are
shown in FIGS. 4, 5a, and 5b as being tilted at a 30 degree angle
with respect to the horizontal, the passages can have any
orientation. For example, and as illustrated in FIG. 9, the
passages can pass vertically through the guide. Alternatively, the
passages can pass at an angle of 5, 10, or 45 or more degrees
through the guide. When the angle at which the passages pass
through the guide is different, the bottom surface 50 of the
depressor is reconfigured so that the depressor engages each
dilator at a right angle.
As described above, preferably the depressor engages the distal end
22 of the dilators 20 at a right angle. In an alternate form of the
present invention, the depressor moves parallel to the direction of
dilator movement through the guide. In particular, the depressor
may be located on a track in the housing by which the depressor
moves downwardly against the dilators at the same angle as the
dilators extend through the guide.
A variety of means for selectively attaching the guides to the
cartridge other than the engagement with the grooves described
above are available. For example, the guide may snap into place or
be press-fit into the housing, be held in place by spring-loaded
pins which pass through the cartridge wall into the guide, or
simply be supported by a ledge extending inwardly from the wall.
Also, a variety of means for selectively attaching and detaching
the fourth side to access the guides are possible.
Also, the guide may actually comprise a portion of the housing
instead of a separate element. For example, the guide may comprise
a molded section of plastic having passages or the like
therethrough which is directly a part of the outer wall.
As described above, the stop means preferably comprises friction
between the dilators and the guide. In this form of the invention,
the guide is preferably constructed of rubber or a similar
"stretchable" and high-friction material. The guide, however, may
be constructed of plastic or a similar rigid material, with each
passage lined with rubber or a similar material.
Also, the stop means for retaining the dilators in the template may
comprise something other than the friction between the dilators and
the guide. For example, a thin pierceable member such as a plastic
sheet may be located over the open end of the housing.
Alternatively, a removable panel may be located across the open end
of the housing, the panel removed when the housing is placed on the
scalp, there by allowing the dilators to be pressed into the
incisions in the scalp.
A second form of the present invention is illustrated in FIG. 7.
FIG. 7 illustrates a cartridge 100 for use with an automated gun
101 or other remote automatic triggering or firing device of the
type commonly used and found in hospitals and medical offices. Such
mechanisms are commonly used to place items such as tissue
staples.
In general, the cartridge 100 comprises a tubular housing 102
rotatably connected to a base 104. An actuator 106 passes through
the base 104 and into the housing 102 for pressing a dilator 20
therein out of the housing and into the scalp of a patient.
The housing 100 is cylindrical in shape, having a first end 108 and
second end 110. The first end of the housing 108 is enclosed, while
the second end 110 is open.
The housing 100 is hollow, except for a number of tubes or passages
112 extending inwardly from the first end 108. Each tube 112 has a
diameter slightly greater than that of a dilator, and having a
slightly longer length. Preferably, the tubes 112 are spacedly
located about the outer periphery of the housing 102, and are open
at both ends.
An axle 114 passes from the first end of the housing 102 to the
base 104. The axle 114 passes along the centerline of the housing
102, allowing the housing 102 to rotate.
The base 104 has a first end 116 for mating engagement with the
second end of the housing 102. The first end 116 of the base is
thus circular in shape, comprising an outer wall and inner hollow
interior space.
The base 104 includes a second end 118 which is adapted for mating
engagement with a triggering device or gun 101. In the embodiment
illustrated, the second end 118 has a generally rectangular
shape.
An aperture 120 is located in one surface of the second end 118 of
the base 104, forming a passage into the interior of the base. The
actuator 106 is generally "L"-shaped, extending from the aperture
through the base and into the housing 102. A first end of the
actuator 106 extends upwardly to the aperture 120 for engagement by
a trigger mechanism in the gun 101. A second end of the actuator
106 is located adjacent the end of one of the tubes 112.
Stop means releasably retain the dilators 20 in the tubes 112. The
stop means preferably comprises friction caused by a slight
interference fit between the dilator and the housing.
In use, a dilator 20 is placed in each of the tubes 112, with the
tapered point facing outwardly. The base 104 of the cartridge 100
is located in a gun 101, and one of the tubes 112 is aligned with
the second end of the actuator 106.
The surgeon actuates the gun 101, moving the actuator 106 towards
the first end of the housing. The second end of the actuator 106
engages the end of the dilator 20 in the aligned tube, pressing the
dilator through the tube and into the incision pre-formed in the
scalp according to the present invention. The surgeon lifts the gun
101 upwardly so that the housing 102 clears the end of the dilator,
and proceeds to place the next dilator.
A surgeon places the next dilator by rotating the housing 102 with
respect to the base 104, until the second end of the actuator 106
is aligned with another tube containing a dilator. The gun is again
triggered, with the next dilator forced into the scalp.
In this form of the invention, the tube 112 holding the dilator 20
is located close to the outer edge of the housing 102, so that the
next dilator can be placed very close to the last. Further, the
range of movement of the actuator 106 is chosen so that the dilator
20 is pressed the appropriate distance into the scalp.
In this embodiment, the stop means may comprise a separate element
such as a rubbery gasket through which the dilator extends, or a
membrane or plate extending across the open end of the tubes which
is either pierceable or movable when the dilators are depressed
into the scalp.
Further, the tubes or passages in which the dilators are located
can be arranged in a variety of configurations. A third embodiment
device of the present is illustrated in FIG. 8. In this embodiment,
several dilators are placed in the scalp automatically when a
surgeon operates a gun.
In particular, this cartridge 200 is nearly identical to that
described above, except the tubes 212 in a housing 202 thereof are
configured to receive multiple dilators 20. In the embodiment
illustrated, each tube 212 is sized to receive seven dilators. The
tube 212 thus includes eight distinct tubes or conduits 213, each
of which holds a single dilator. Again, each end of each tube 212,
and each passage 213 therein, is open.
In use, when a surgeon actuates the gun or automated firing device,
the actuator presses all of the dilators in a tube 212 into
incisions of a corresponding configuration made in the scalp
according to the present invention. In the configuration
illustrated, all eight dilators in the passages in a single tube
are pressed into the scalp.
It is possible to have a wide variety of numbers of tubes and
passages therein, for placing a different number of dilators.
Further, the passages can be arranged in a wide variety of
configurations, whereby the multiple dilators are placed in the
scalp in a specific configuration.
FIG. 9 illustrates a fourth embodiment device of the present
invention. In particular, this variation of the device if similar
to that illustrated in FIG. 4, except that it is automated.
In this form of the invention, a cartridge 300 includes a housing
302 with a first bottom open end 304 and second gun-engaging end
306. A dilator guide 308 and depressor 310 are located inside of
the housing 302.
The second end 306 of the housing 302 is shaped for engagement with
the end of a triggering device, such as a spring-loaded or
air-powered gun. In the form illustrated, the second end 306 is an
elongate, somewhat rectangular shaped member.
The remainder of the housing 302 is box-shaped, except that the
first end 304 is open. Similar to the cartridge 32 illustrated in
FIGS. 4, 5a and 5b, a removable dilator guide 308 is located within
the housing, recessed a short distance from the open first end
304.
Preferably, a surgeon can open and close one side of the housing
302 to access the guide 308, similar to the manner described above
in the first embodiment.
The depressor 310 is located between the guide 308 (at the end of
the dilators therein) and the second end 306 of the housing 302.
The depressor 310 has a perimeter shape which matches the inside
shape of the housing 302, to be freely moveable between a first
retracted position and a second depressed position.
A bottom surface 312 of the depressor 310 is adapted to press on
the dilators at a right angle, as discussed above in more detail.
Preferably, the depressor 310 is connected to an actuator 316 which
extends into the second end 306 of the housing for engagement with
the gun.
Means for biasing the depressor 310 in the form of a pair of
springs 318, 320 maintain the depressor 310 in a normally retracted
position. The springs 318, 320 are chosen so that upon firing of
the gun, the actuator 316 moves against the spring force, pressing
the actuator downwardly against the dilators.
In use, a surgeon inserts a loaded dilator guide 308 into the
housing 302 of the cartridge. Once loaded, the surgeon inserts the
cartridge 300 into a gun. The surgeon then places the open end 304
of the cartridge 300 against the scalp of a patient in the desired
location.
The surgeon triggers the gun, effectuating movement of the actuator
316 and pressing the depressor downwardly against the dilators and
the opposing spring force. The dilators are pressed through the
passages in the guide 308 and into the corresponding incisions in
the scalp. Once the dilators are placed, the springs 318, 320 bias
the depressor back upwardly to the retracted state, when a new
loaded dilator guide can be inserted into the cartridge.
In accordance with this method, numerous dilators are
simultaneously placed into the scalp using an automated machine.
Once again, the particular location and pattern of the dilators is
effectuated by choosing a guide having a specific configuration of
dilator-holding conduits.
Other configurations of dilators can be used. For example, FIG. 10
illustrates a second form of dilator 400 for use in the methods and
apparatus of the present invention. The dilator 400 is similar to
that described above, except that it has a hollow passageway 402
along the centerline thereof. This dilator 400 has the effect of
coring a section of tissue from the patient when the dilator is
inserted and then removed.
FIGS. 11-13 illustrate a fifth embodiment of the dilator device for
use in the present invention. In this embodiment, the device for
simultaneously placing dilators are interengaging plates or
templates, with the dilators comprising a series of spikes on one
of the templates. In particular, a first or female template 500
comprises a thin base member 502 having a top surface 504 and a
bottom surface 506. A number of cylindrically shaped guides 508
depend downwardly from the bottom surface 506 of the template, each
having a tapered or bevelled distal end 509. Each guide 508 has a
length nearly equal to the depth the hair grafts must be placed
into the tissue of the patient to maximize graft survival.
A passage 510 extends through the top surface 504 of the template
down through each of the guides 508. The location and pattern of
each of the guides 508 on the template 500 is preselected to match
the spacing of later to be placed hair grafts 532.
A second or male template 512 comprises a thin base member 514
having a top surface 516 and bottom surface 518. A number of spikes
or probes 520 extend downwardly from the bottom surface 518 of the
template.
Preferably, the spikes 520 are longer than the passages 510 through
the female template 500, and have a smaller outside diameter than
the diameter of the passages 510 through the guides 508 and
passages through the guides of a third template described below.
The spikes 520 have a distal end which tapers to a point. The
spikes 520 are arranged in the same pattern as the guides 508 on
the female template.
As illustrated in FIG. 13, a third template 522 comprises a base
plate 523 having a top surface 524 and bottom surface 526. A number
of cylindrical guides 528 depend downwardly from the bottom surface
526 of the template. A passage 530 extends through the template 522
and each of the guides 528. Preferably, the outer dimension of each
of the guides 528 is smaller than the size of the passage 510 of
the female template 500. The guides 508 are arranged in the same
pattern as the guides 508 in the female template 550, for mating
engagement therewith.
In use, as illustrated in FIGS. 12 and 13, a surgeon presses the
male template 512 into the female template 500. In particular, the
surgeon aligns the spikes 520 of the male template with the
passages 510 through the guides 508 in the female template 500. The
surgeon presses the two templates 500, 512 together until the
bottom surface 518 of the male template 512 engages the top surface
504 of the female template. When engaging one another, the spikes
520 and guides 508 cooperate to form "dilators" for placement in
the tissue 534 of the patient. The surgeon places the combination
on the scalp of the patient and presses downwardly until the bottom
surface 506 of the female template 500 contacts the scalp,
preventing further movement. The surgeon then pulls the male
template 512 from the female template 500, leaving the female
template in place.
When the female template 500 is in place, the passages 510
therethrough form cavities in the tissue of the patient into which
hair grafts 532 may be inserted. In particular, the surgeon or an
assistant places hair grafts 532 into each of the passages 530 of
the third template 522, and then the surgeon presses the third
template into engagement with the female template 500 which is
engaging the patient.
When the surgeon presses the third template 522 into the female
template 500, each hair graft 532 is effectively positioned in the
tissue of the patient. Preferably, the surgeon then presses the
male template 512 into the other two templates, whereby the spikes
520 engage the hair grafts 532 and push them into the bottom of the
formed cavities. The surgeon then removes all of the templates,
leaving the hair grafts 532 in place in the tissue of the
patient.
In the above-described device, the templates may comprise
substantially rigid members made of plastic or similar material.
Preferably, however, so that the device can conform to the varying
shape of the patient, the base of each template is constructed of a
slightly flexible material, such as a rubber or flexible plastic.
The spikes and guides, however, is preferably constructed of a
rigid material which easily penetrates tissue.
Further, the size and location of the guides and corresponding
spikes may vary. For example, the guides and spikes may be located
on their respective bases in a variety of patterns for use in
positioning hair graft in the same variety of patterns on the
scalp. Also, the guides, and thus the matching spikes, may vary in
size, both between different template, and even on the same
template, depending on the size of hair graft to be implanted.
FIGS. 14a-d and 15-17 illustrate a sixth embodiment of the present
invention. The sixth embodiment of the invention is similar to the
last embodiment, except that four plates (instead of three) are
preferably utilized for creation of cavities in tissue and
placement of hair grafts.
This form of the invention comprises a incision catheter plate 602,
incision needle plate 604, hair graft catheter plate 606, and hair
graft needle plate 608.
FIG. 14a illustrates the incision catheter plate 602. This plate
602 comprises a base 610 having a number of hollow catheters 612
extending downwardly therefrom. Each catheter 612 is hollow and
aligned with a passageway or bore passing through the base 610.
Means for aligning the plates are provided. Preferably, the means
include a guide post 613a,b extending upwardly from the base 610 of
the plate 602 at each end thereof. In particular, the each post
613a,b preferably rises upwardly from the base 610 about 22-30 mm
from a small extension of the base 610. As illustrated, the posts
613a,b are cylindrical in shape, having rounded top ends.
FIG. 14b illustrates the incision needle incision plate 604. The
plate 604 comprises a base 614 having a number of spikes 616
extending downwardly therefrom. Preferably, the base 614 has
approximately the same dimensions as the base 610 of the incision
catheter plate 602. The spikes 616 are arranged on the bottom of
the plate 604 in the same pattern and position as the catheters 612
of the incision catheter plate 602, whereby a user may align the
spikes 616 with the catheters 612 and press the spikes into
engagement with the catheters. Each spike 616 is preferably a
cylindrical member which near the free end thereof tapers to a
sharp point.
A bore 618a,b is located in the base 614 of the incision needle
plate 604 at an extension of each end of the base. The bores 618a,b
are positioned in the plate 614 for alignment with the posts 613a,b
rising upwardly from the incision catheter plate 602.
In use, and as illustrated in FIGS. 15 and 16, a user aligns the
bores 618a,b of the incision needle plate 604 with the posts 613a,b
of the incision catheter plate 602 and presses the two plates
together until the base 614 of the incision needle plate 604 is
resting on top of the base 610 of the incision catheter plate 602.
As illustrated in FIG. 16, when the two plates 602, 604 engage one
another, the spikes 616 and catheters 612 interengage to form solid
"needles" for penetration of the tissue of a patient.
The catheters 612 are each preferably about 5-9 mm, and most
preferably about 5-7 mm long, and 1-4 mm in inner diameter. The
outer diameter of each spike 616 is preferably nearly equal, but
always slightly less than, the inner diameter of each catheter 612.
This allows each spike 616 to pass into each catheter 612 and leave
little if any space therebetween, whereby tissue can not become
entrapped between the interengaging spikes/catheters when they are
pushed into the scalp. Further, the lengths of the catheters 612
and spikes 616 are chosen so that their total length is sufficient
to create an aperature in the tissue of sufficient depth for proper
hair graft placement (normally about 6-8 mm).
Once pressed into the tissue as illustrated in FIG. 16, the
incision needle plate 604 is removed. The incision catheter plate
602 remains in place, with the catheters 612 thereof forming
apertures in the tissue for placement of hair grafts.
Preferably, the user utilizes the hair graft catheter plate 606 and
hair graft needle plate 608 for placement of the hair grafts.
The hair graft catheter plate 606 comprises a base 620 having a
number of catheters 622 extending downwardly therefrom. As with the
catheters 612 of the incision catheter plate 602, these catheters
622 are preferably hollow, and aligned with passages or bores
passing through the base 620. The catheters 622 are arranged on the
bottom of the base 620 for engagement with the catheters 612 of the
incision catheter plate 602.
Bores 624a,b extend through an extension portion of each end of the
base 620. The bores 624a,b are position on the base 620 for
alignment with the posts 613a,b of the incision catheter plate
602.
The hair graft needle plate 608 comprises a base 626 having a
number of cylindrical, blunt end rods 626 extending downwardly from
a bottom surface thereof. The rods 626 are arranged for engagement
with the catheters 612, 622 of the incision catheter plate 602 and
hair graft catheter plate 606, respectively.
Bores 630a,b are located in the base 626 of the plate 608 at
extension portions thereof. The bores 630a,b are sized and
positioned to allow the posts 613a,b of the incision catheter plate
602 to pass therethrough.
In use, a user loads hair grafts into the catheters 622 of the hair
graft 632 catheter plate 606. The user then aligns the bores 624a,b
of this plate 606 with the posts 613a,b of the incision catheter
plate 602, and presses the hair graft catheter plate 606 downwardly
until base 620 thereof engages the base 610 of the incision
catheter plate 602 (see FIG. 17).
The catheters 622 of the hair graft catheter plate 606 are sized to
slide within the catheters 612 of the incision catheter plate 602.
For example, when the inner diameter of each catheter 612 of the
incision catheter plate 602 is about 1.7 mm, the outer diameter of
each hair graft catheter plate catheters 622 is about 1.2 mm.
Further, it is preferred that the hair graft catheter plate
catheters 622 extend into the tissue to almost an equal depth of
the incision catheter plate catheters 612. To compensate for the
thickness of the incision catheter plate base 610, this means the
hair graft catheter plate catheters 622 must be slightly longer
that the incision catheter plate catheters 612.
The user utilizes the hair graft needle plate 608 to press the hair
grafts 632 from the catheters 612, 622. The user aligns the bores
630a,b of the hair graft needle plate 608 with the posts 613a,b of
the incision needle plate 602 and presses the hair graft needle
plate 608 downwardly, as illustrated in FIG. 17. Once fully
depressed, the user lifts the combined and stacked incision
catheter plate 602, hair graft catheter plate 606 and hair graft
needle plate 608 from the tissue, leaving the hair grafts 632
implanted in the tissue.
The rods 622 of the hair graft needle plate 608 preferably have an
outer diameter which is slightly less than the inner diameter of
the hair graft catheter plate catheters 628. The rods 622 are
preferably long enough so that they extend to near the bottom of
the incision catheter plate catheters 612 when engaged therewith.
One of the advantages of using a fourth plate--the hair graft
needle plate 608--instead of the three plate arrangement described
above is that the lengths of the rods 622 can be chosen so that
they do not extend outwardly from the ends of the catheters 612
like would happen if the spikes 616 of the incision needle plate
604 were used for this task. This prevents the user from driving
the hair grafts into the tissue of the patient.
Second, the shape of the rods 622 allows for more effective
displacement of the grafts from the catheters than when using a
pointed spike. Use of the flat ended rod 622 presents less risk of
damage to the hair graft.
As with the previously-described form of the invention, the plates
may comprise substantially rigid members made of plastic or similar
material. In some instances, however, the plates may be constructed
of a slightly flexible material so that they can conform to the
tissue contour of the patient. The spikes, rods, and catheters,
however, are preferably constructed of a rigid material which
easily penetrates tissue.
While the spikes, rods, and catheters are illustrated in two rows
of spaced-apart members, their location may vary. In particular,
the spikes, rods and catheters may be arranged in any variety of
patterns for use in locating hair grafts in the same variety of
patterns in the scalp.
Advantageously, in this form of the invention, the interengagement
of the incision needle plate spikes 616 with the incision catheter
plate catheters 612 forms, in essence, a single rigid "needle" for
forming an aperture in tissue or for disposition in a pre-incision
cut made therefor according to the present invention. This is
advantageous over use of a regular dilator or a catheter for
several reasons. First, use of a catheter alone may result in
tissue being forced into the interior of the catheter, thus
blocking hair graft placement. Alternatively, use of a dilator
alone can be difficult, because when the dilator is removed, the
aperature in the scalp often closes, preventing positioning of the
hair graft in the tissue.
Further, in this and the last form of the invention, the catheters
or guides and spikes and rods can be located at an angle of other
than perpendicular to the base of each respective plate. In this
manner, a user can create an aperature in the tissue which lie at
an angle other than perpendicular thereto. This is important, for
most hair grows naturally from the scalp at other than an angle of
perpendicular thereto. Use of template or plates having members
extending at an angle of other than perpendicular to the scalp
allows placement of hair grafts at a similar angle in the
scalp.
Another aspect of the last two forms of the invention which is
advantageous is that a hair grafts can be pre-loaded into a number
of plates/templates for later use. With several separate
plates/templates pre-loaded, a user can very quickly create
apertures with the other members and then place large numbers of
hair grafts very quickly.
The spikes may have forms other than that described above. In
particular, the spikes may have a "body" which is smaller in
diameter than the tip. The spikes may also have a tip which
comprises a thin blade-like element as opposed to a point. In some
instances, it might also be desirable for the spike to be hollow
instead of solid.
The wall of the catheter at the end thereof may be tapered or sharp
to aid in the insertion of the device into the tissue.
Alternatively, instead of the wall of the catheter ending
perpendicular to the length of the wall, the end of the catheter
may be entirely tapered.
Also, the shapes of the plates (or bases thereof) may vary widely
dependent upon the area of tissue in which the grafts are to be
planted. For example, the plates may be round, square, or
irregular-shaped. The means for aligning the plates may include
other types of guides or other similar members known in the
art.
Yet another variation of the dilator device for use in the present
invention is illustrated in FIGS. 18-19. In this variation of the
invention, the templates or plates of the above-described versions
of the invention are "mechanized" for faster graft placement.
The device 700 of this form of the invention comprises a first or
lower plate 702 having two upwardly extending guides 704, 706, an
upper or second plate 708 movably mounted on the guides, and a
cartridge 710 located between the upper and lower plates.
The lower plate 704 comprises a base member 712 having a number of
hollow catheters 714 extending downwardly therefrom and aligned
with bores 716 passing through the base. The catheters 714 are
arranged on the base 712 in the same pattern in which hair grafts
will ultimately be implanted in the tissue of a patient.
The base 712 is preferably fairly rigid and constructed of a
durable, sterilizable material, such as plastic. The base 712 is
preferably elongate in shape, having first and second ends located
outwardly of the bores 716.
Preferably, means for guiding the upper plate 708 between a first
raised and a second lowered position are provided. The means
preferably comprises guides 704, 706 extending upwardly from the
ends of the plate 702.
The first guide 704 is a flat member extending upwardly from its
connection to the base 712 of the lower plate 702. The guide 704 is
fairly wide to accommodate an indentation 718 therein. A stop 720
is located at an end of the guide 704 located opposite the lower
plate 702, for limiting the upward movement of the upper plate 708
thereon.
The second guide 706 is a cylindrical post extending upwardly from
the end of the base 712 of the lower plate 702 opposite the first
guide 704. Both the first and second guides 704, 706 are preferably
made of a durable and sterilizable material, and have a length
sufficient to allow travel of the upper plate 708 between the
positions described below.
The upper plate 708 is preferably shaped similar to the lower plate
702, comprising a base 722 having a number of spikes 724 extending
downwardly therefrom. The spikes 724 are cylindrical members having
pointed tips which are sized for insertion into the hollow
catheters 714 of the lower plate 702. The length of each spike 724
is chosen such that it extends slightly from the end of the
catheter 724 when pressed downwardly therethrough as described
below.
First and second passages are located in the upper plate 708 for
acceptance of the first and second guides 704, 706, whereby the
upper plate 708 may slide up and down along the guides.
As illustrated in FIG. 18, the cartridge 710 comprises a wheel
rotatably mounted on the second guide 706 between the lower and
upper plates 702, 708. The cartridge 710 preferably has a radius
equal to the distance between the first and second guides 704,
706.
A number of bores 726 pass through the cartridge 710 from a top
surface 728 to a bottom surface 730 thereof. The distance between
the top and bottom surfaces 728, 730 is great enough that a hair
graft may be positioned inside each bore 726. Preferably, the bores
726 are arranged in sets about the cartridge, one set is
illustrated in FIG. 18. Other sets of bores 726 (not illustrated)
are located about the lines illustrated on the top surface 728 of
the cartridge 710.
Each set of bores 726 includes a number of bores equal in number to
the spikes 724 and catheters 714, and arranged in the same
pattern.
Means for aligning the sets of bores 726 of the cartridge 710 with
the spikes 724 and catheters 714 of the plates 702, 708 are
provided. Preferably, this means comprises a number of beads 732
located on the cartridge 710 and the indentation 718 in the first
guide 704.
The beads 732 are located on the outwardly facing surface of the
outer edge of the cartridge 710. These beads 732 extend slightly
outwardly of the cartridge for engagement with the indentation 718
in the first guide 704. The beads 732 are positioned on the
cartridge 710 such that when a bead 732 engages the indentation
718, one of the sets of bores 718 is aligned with the spikes 724
and catheters 714.
Use of this form of the invention is as follows. A user aligns an
empty set of bores 726 of the cartridge 710 with the spikes 724 and
catheters 714. The user accomplishes this by raising the upper
plate 708 along the guides 704, 706, and then rotating the
cartridge 710 until one of the beads 732 engages the indentation
718.
The user then presses the upper plate 706 downwardly, passing the
spikes 724 through the bores 726 in the cartridge and into the
catheters 714. At this time, the tips of the spikes 724 protrude
slightly from the ends of the catheters 714, such that the spikes
and catheters interengage to form "needles." The user then presses
the device 700 downwardly so that the spikes 724 and catheters 714
enter the tissue of a patient. The user stops when the lower plate
702 rests on the tissue of the patient.
The user then raises the upper plate 708 until the spikes 724 are
located above the cartridge 710. The user rotates the cartridge 710
until a set of bores 726 containing hair grafts is aligned with the
spikes 724. The user or another party can load any of the other
sets of bores 726 with hair grafts before or during the procedure.
In particular, a user places hair grafts into any or all of the
bores 726.
Once aligned, the user presses the upper plate 708 downwardly. As
the upper plate 708 moves downwardly, the spikes 724 press the hair
grafts in the bores 726 down into the catheters 714. The user then
raises the upper plate 708 and removes the device 700 from the
tissue. A hair graft is left in the tissue of the patient in each
spot corresponding to where a catheter 714 penetrated the tissue
and a hair graft was pressed therein.
The user then aligns an empty set of bores 726 so that the spikes
708 can be lowered therethrough and used to reinsert the device
into the tissue of the patient in a new location.
Advantageously, this device 700 allows a user to preload several
sets of bores 726 with hair grafts, whereby the device may be used
to place several sets of hair grafts in very quick succession.
As illustrated in FIG. 19, a similar result can be achieved when
the cartridge 710 used with the device is not a wheel but comprises
a single segment. In this version, a cartridge 740 takes the form
of a rectangular segment having a first end 742 and a second end
744. Bores 746 like those described above pass through the
cartridge 740.
The first end 742 of the cartridge 740 is designed for engagement
with the first guide 704. In particular, the first end 742 of the
cartridge 740 preferably includes a bead 748 extending outwardly
therefrom for engagement with the indentation 718 in the first
guide 704.
The second end 744 of the cartridge 740 is designed for engagement
with the second guide 706. Preferably, the second end 744 of the
cartridge 740 has a semi-circular cut-out.
In use, the user presses the second end 744 of the cartridge 740
into engagement with the second guide 706. The user rotates the
cartridge 740 into place when the bead 748 thereon engages the
indentation 718 in the first guide 704.
A user utilizes an empty cartridge 740 when inserting the device
700 into the tissue of a patient. The user utilizes a cartridge 740
having bores filled with hair grafts when ready to insert the
grafts.
Advantageously, the user may replace cartridges 740 as needed, and
when a user has a number of cartridges 740, several may be
pre-loaded with hair grafts for quick placement of large numbers of
grafts.
In this form of the present invention, it is also possible for
device 700 to be configured for placement of hair grafts at an
angle into the tissue. The catheters, spikes and bores may be
angled (at other than perpendicular to the plates/cartridge) for
placement of the grafts. In that instance, the guides 704, 706
should also be angled to permit sliding of the upper plate 708 up
and down while the spikes move in and out of the
bores/catheters.
It has been found that insertion of the dilators according to the
above directly into the tissue can be difficult, particularly where
a large number of grafts are to be performed. The numerous dilators
distribute the force necessary to puncture the tissue making
accurate and trouble-free insertion of the dilators difficult.
Accordingly, and pursuant to the present invention the device,
method and kit are provided.
Turning to FIGS. 20 and 21 an incision device 900 is shown which is
adapted to make a pattern of incisions in the tissue to correspond
to the pattern of the dilators to be received therein. The device
900 has a rigid body 902 with at one end a handle 904. Opposite the
handle 904 are a plurality of cutters 906, only a portion of the
number shown in the drawing, which project from the body 902. These
cutters 906 are each adapted to make an incision in the tissue 907
to receive a dilator.
While the cutters 906 may be rigid, solid needles, preferably each
is defined as a blade having a tapered knife-edge 908. As shown in
FIGS. 21 and 22A-B the cutters 906 are arranged in a pattern which
corresponds to the predetermined pattern for the dilators. It has
been found that providing cutters 906 such that each knife-edge 908
makes an incision of about 0.055-0.060 inches deep in the tissue
907 is well suited to receive the dilators.
With continuing reference to FIGS. 22A-B the pattern of the cutters
906 can be, as shown in FIG. 22A to make in a single motion an
entire row of incisions or can be spaced such that multiple spaced
strikes must be made to complete the pattern. That is, the number
of cutters would be halved requiring a first strike, indexing over,
and a second strike to form the desired pattern of incisions. As
shown in FIGS. 22A-C, the cutters 906 of each row are closely
spaced to define a minimum spacing for the dilators and grafts.
Each row of the pattern formed by the cutters 906 is thus comprised
of identical rows and columns of the cutters 906. To facilitate
incision and as shown in FIGS. 22B-C, the lengths of the cutters
906 are preferably graduated or staggered so that the entire array
of cutters 906 do not penetrate the tissue 907 simultaneously and
thereby disadvantageously distribute the penetration forces among
all the cutters 906. That is, when the incision device 900 is
pressed against the tissue, only a portion of the cutters 906, i.e.
one or several columns of the cutter array, are penetrating the
outer surface of the tissue 907. Furthermore, the surgeon can rock
the device 900 back and forth to make the aforesaid incision
pattern defined by the cutter array.
With reference to FIG. 20 the device and method of the present
invention may include a guide block 910. The guide block 910
includes a base 912 configured and adapted to rest and support the
block 910 on the tissue 907 adjacent the area to be incised. To
guide the motion of the incision device 900 the guide block 910 has
a guide surface 914 which may be vertical or inclined as shown in
the drawings. As shown, the guide surface 914 acts to guide the
incision device 900 in its movement toward the tissue 907 to enable
the surgeon to accurately align the device with the location on the
tissue to be incised.
With continue reference to FIGS. 20 and 21, the guide surface 914
may include a plurality of grooves 916 at spaced locations thereon.
To cooperate with the grooves 916 the incision device body 902
includes a rudder 918 projecting therefrom which is sized to be
closely received in each groove 916. By engaging the rudder 918 in
a groove 916 the movement of the device 900 to the tissue 907 can
be easily guided and steadied. Further, where side-by-side incision
patterns are to made in the tissue 907, the grooves 916 and rudder
918 act to index the placement of the incisions. A first set of
incisions are made and the surgeon indexes the device 900 over to
register the rudder into the adjacent groove 916 to make the next
pattern of incisions, By sizing the pattern of the cutters 906 and
the location of the grooves 916, a consistent larger pattern of
incisions can be made in the tissue 907 to receive the grafts.
To make the incision pattern, the surgeon moves the incision device
900 along the guide surface 914 until the cutters 906 engage the
tissue 907. The surgeon thereafter stands the device 900 upright
and presses down to make the pattern of incisions, If necessary,
the surgeon may rock the device from side-to-side to urge the
cutters 906 to make the incisions, Once the incisions are made the
device 900 is removed from the tissue 907.
Because the incisions are made with the cutters 906, the openings
for the grafts are smooth and precise and are made with reduced
trauma to the tissue. This, it is believed, will promote healing
and acceptance of the graft as well as reduce infection.
After the incisions have been made, the dilators as described above
are inserted into the incisions. Since the incision pattern is
selected to match the dilator pattern, multiple dilators can be
simultaneously inserted into the tissue. Preferably, the dilators
are of the type described with reference to FIGS. 18 and 19
hereof.
The incision device 900 and the dilator device as well as the guide
block may be cooperatively adapted to be sold as a kit. The pattern
of cutters 906 and dilators would correspond to a selected pattern
for the grafts. The graft pattern may vary depending upon the
desired density of the grafts to be implanted.
It will be understood that the above described arrangements of
apparatus and the method therefrom are merely illustrative of
applications of the principles of this invention and many other
embodiments and modifications may be made without departing from
the spirit and scope of the invention as defined in the claims.
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